Benzinga | Nov 9, 2021 11:34AM EST

Tonix Pharmaceuticals Presents Phase 1 Formulation Development Data For TNX-601 CR In A Poster Presentation At CNS Summit 2021

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced a poster presentation of results from its open-label, Phase 1 clinical study of TNX-601 CR (tianeptine oxalate and naloxone controlled-release tablets). Tonix is developing TNX-601 CR as a potential treatment for major depressive disorder (MDD) as well as post-traumatic stress disorder and neurocognitive dysfunction associated with corticosteroid use. A copy of the poster is available under the IR Events tab of the Investors section of the Tonix website at www.tonixpharma.com. CNS Summit 2021 is taking place November 7th -- 10th in Boston, Mass. The poster presentations by Greg Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals, took place on November 8th and will also be presented on November 9th from 5:00 pm -- 7:00 pm ET.

The poster, titled, "TNX-601 CR*: a Once-Daily Formulation of Tianeptine in Development for the Treatment of Major Depressive Disorder" provides data related to the Phase 1 pharmacokinetic study in healthy subjects that assessed several novel modified-release (MR) prototype formulations of tianeptine oxalate. The study showed that the selected TNX-601 MR1 demonstrated pharmacokinetics appropriate for once-daily dosing with minimal food effect, which is a potential treatment adherence advantage over three times per day dosing of immediate release tianeptine sodium. This MR prototype was selected in the development of the final formulation of TNX-601 CR as a once-daily treatment for MDD.

"We believe that these Phase 1 findings support our upcoming Phase 2 study of once-daily TNX-601 CR for MDD that we expect to initiate in the first half of 2022," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. "Tianeptine products have been approved in Europe and other countries around the world and marketed as prescription drugs for the treatment of depression for more than three decades. Based on our Phase 1 results, we believe that with respect to plasma tianeptine and its primary metabolite, TNX-601 CR would meet the bioequivalence standard for daily dosing of these immediate release products. No tianeptine-containing product has been approved by the U.S. Food and Drug Administration (FDA). TNX-601 CR's proposed mechanism of action is distinct from any antidepressant approved in the U.S for chronic or long-term use."

Tonix previously completed a Phase 1 clinical trial for formulation development outside of the U.S. Based on this study, the final formulation of TNX-601 CR to be used in Phase 2 testing will be 39.4 mg tianeptine oxalate and 1 mg naloxone for once daily treatment of MDD. Naloxone is included in the formulation to mitigate the potential for high dose parenteral abuse. Tianeptine has weak off-target activity at the ?-opioid receptor that presents the potential for parenteral abuse with doses on the order of eight to 80 times the therapeutic daily dose for depression. The Phase 2 study design is expected to be a randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of TNX-601 CR monotherapy compared to placebo in MDD. Treatment duration will be six weeks, preceded by up to five weeks in screening and followed by a two-week safety follow-up period (total up to 13 weeks of participation). We plan to randomize approximately 260 individuals with MDD at a 1:1 ratio to two arms of 130 each for drug and placebo at approximately 25-30 U.S. sites. The primary efficacy endpoint will be the change from baseline to Week 6 in the Montgomery-?sberg Depression Rating Scale (MADRS) total score. Enrollment is estimated to start in the first half of 2022, pending clearance of the Investigational New Drug application.